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T and B Cell Responses in Autoimmune Diseases (SRA01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01947036
Recruitment Status : Terminated (Lack of enrollment.)
First Posted : September 20, 2013
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Autoimmunity Centers of Excellence
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
The study aims to establish whether defects in immune cell function are shared across multiple autoimmune diseases and whether those problems match to similar genes in the cells.

Condition or disease
Type 1 Diabetes Mellitus Multiple Sclerosis Arthritis, Rheumatoid Crohn's Disease Psoriasis

Detailed Description:

This is a non-randomized, multi-center clinical research study. Subjects who are healthy or have a confirmed or suspected diagnosis of type 1diabetes, multiple sclerosis, psoriasis, Crohn's disease, or rheumatoid arthritis will be asked to donate a blood sample. No follow-ups are planned.

Investigators will:

  • evaluate immune cells from subjects enrolled in this study and match the differences to types of immune cells known to cause autoimmune diseases
  • investigate a particular disease pathway: the IL23R signaling cascade.
Study Design
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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: T and B Cell Responses Across Autoimmune Diseases
Study Start Date : January 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Healthy Subjects
Healthy adult controls (no auto-immune disease)
Subjects with Crohn's Disease
Diagnosed with or suspected of having Crohn's disease (CD)
Subjects with Rheumatoid Arthritis
Diagnosed with or suspected of having rheumatoid arthritis (RA)
Subjects with Type 1 diabetes
Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM)
Subjects with Multiple Sclerosis (MS)
Diagnosed with or suspected of having MS
Subjects with Psoriasis
Diagnosed with or suspected of having psoriasis (Ps)


Outcome Measures
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Primary Outcome Measures :
  1. Identify shared defects in T and B cell function by disease classification [ Time Frame: One-time blood draw ]
    The study aims to establish whether defects in T and B cell function are shared across multiple immune-mediated diseases and whether these are driven by shared genetic risk variants.


Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who are healthy or have a confirmed or suspected diagnosis of type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), psoriasis (Ps), Crohn's disease (CD), or rheumatoid arthritis (RA) will be invited to donate a blood sample. No follow-ups are planned.
Criteria

Inclusion Criteria:

-Subject or subject's parent or legal guardian has provided written informed consent

-For healthy donors: Healthy individuals between 18 and 60 years of age, inclusive

  • For all subjects with an autoimmune disease:

    1. Adults between 18 and 60 years, inclusive, diagnosed with or suspected of having one of the following five diseases: adult forms of rheumatoid arthritis (RA), type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), Crohn's disease (CD), Psoriasis (Ps)
    2. Or Children from 8 years up to 18 years inclusive, diagnosed with or suspected of having type 1 diabetes (TID) or Crohn's disease (CD)

    3. Treatment naïve except for prednisone (or equivalent corticosteroid) <\=10mg/day

      4. For subjects diagnosed with type 1 diabetes:

    1. Clinical diagnosis or suspected diagnosis of T1D
    2. Positive per standard clinical titer levels for anti-insulin antibodies if within 10 days of diagnosis (new-onset T1D); and otherwise one of the following antibodies-anti-GAD65, anti-ICA512/IA2 or anti-ZnT8
    3. Minimum body weight 17kg (≥37.5 pounds)

    4. Disease duration within 1 year

      5. For subjects diagnosed with multiple sclerosis:

    a. EDSS (Expanded Disability Status Scale) 0-5 b. Diagnosis or suspected diagnosis of MS as per Dr. Polman et al. Annals of Neurology 2010 c. Disease duration within 1 year

    6. For subjects diagnosed with rheumatoid arthritis (RA):

    a. Diagnosis or suspected diagnosis of RA (2010 ACR criteria) b. Anti-CCP antibody positive c. Disease duration within 1 year

    7. For subjects diagnosed with Crohn's disease:

    a. Clinical diagnosis or suspected diagnosis of Crohn's confirmed by endoscopy b. Disease duration within 1 year c. Minimum body weight 17 kg (≥37.5 pounds)

    8. For subjects diagnosed with psoriasis:

    1. Psoriasis diagnosis by a dermatologist
    2. Disease duration within 1 year

    3. At least two psoriatic plaques or a single plaque occupying at least 1% of total body surface outside scalp

      Exclusion Criteria:

      1. For healthy donors:

    a. Individuals who are unable or unwilling to donate blood samples b. Individuals with self-reported chronic metabolic diseases such as type 2 diabetes, impaired glucose tolerance or morbid obesity c. Individuals with self-reported acute infection (respiratory or others) or chronic infection (such as HIV,hepatitis B or -C) d. Individuals with self-reported immune-mediated diseases such as multiple sclerosis, type 1 diabetes, primary immunodeficiency e. Individuals with self-reported current or prior history of malignancy f. Individuals who are currently pregnant (self-report) g. Corticosteroid therapy equivalent to >/= 10 mg/day of prednisone within the last 4 weeks h. Immunosuppressive therapy at any time prior to enrollment (such as Cyclophosphamide, Mitoxantrone, Imuran, Cellcept, Methotrexate, Rituximab, Alemtuzumab)

    2. For all subjects with an autoimmune disease:

    a. Pregnant patients b. Pediatric patients unable to donate at least 51 mL of blood per NIH guidelines (no more than 5 mL/kg in a single day and no more than 9.5 mL/kg over any 8 week period) c. Patients with current substance abuse or alcoholism (self-report) d. Patients diagnosed with more than one autoimmune and/or inflammatory disease, exception - asthma is permissible e. Corticosteroid therapy equivalent to > 10 mg/day of prednisone within the last 4 weeks f. Immunomodulatory therapies within the last 12 months (such as Interferon, Glatiramer Acetate, Natalizumab, Fingolimod) g. Immunosuppressive medication at any time prior to enrollment (such as Cyclophosphamide, Mitoxantrone, Imuran, Cellcept, Methotrexate, Rituximab, Alemtuzumab) h. Any prior or current Anti-tumor necrosis factor (anti-TNF) treatments i. Any prior or current use of experimental drugs tested in Phase I, II, or III clinical trials

    3. Diagnosis of ulcerative colitis or indeterminate colitis

    4. Pustular psoriasis, isolated palmoplantar psoriasis, isolated inverse psoriasis and isolated sebopsoriasis.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947036


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
University of Rochester
Rochester, New York, United States, 14642
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City,, Oklahoma, United States, 73104
United States, Texas
Baylor Institute of Immunology Research - Clinical Rheumatology
Dallas, Texas, United States, 75204
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence
Investigators
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Principal Investigator: Chris Cotsapas, PhD Yale University
More Information
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Additional Information:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01947036    
Other Study ID Numbers: DAIT SRA01
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
autoimmune disease
immune-mediated disease
T and B cells immunophenotype
IL23 signaling
genetic risk variants
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Crohn Disease
Multiple Sclerosis
Psoriasis
Diabetes Mellitus, Type 1
Autoimmune Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases
 Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rheumatic Diseases
Connective Tissue Diseases